Carlton, J. orcid.org/0000-0002-9373-7663, Powell, P. orcid.org/0000-0003-1169-3431, Rowen, D. orcid.org/0000-0003-3018-5109 et al. (12 more authors) (2023) Producing a preference-based quality of life measure to quantify the impact of hypoglycaemia on people living with diabetes: a mixed-methods research protocol. Diabetic Medicine, 40 (3). e15007. ISSN 0742-3071
Abstract
Background
Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions. There is a need for a new hypoglycaemia-specific QoL PROM, which can be used directly to inform economic evaluations.
Aims
This project has three aims: (1) To develop draft PROM content for measuring the impact of hypoglycaemia on QoL in adults with diabetes. (2) To refine the draft content using cognitive debriefing interviews and psychometrics. This will result in a condition-specific PROM that can be used to quantify the impact of hypoglycaemia upon QoL. (3) To generate a preference-based measure (PBM) that will enable utility values to be calculated for economic evaluation.
Methods
A mixed-methods, three-stage design is used: (1) Qualitative interviews will inform the draft PROM content. (2) Cognitive debriefing interview data will be used to refine the draft PROM content. The PROM will be administered in a large-scale survey to enable psychometric validation. Final item selection for the PROM will be informed by psychometric performance, translatability assessment and input from stakeholder groups. (3) A classification system will be generated, comprising a reduced number of items from the PROM. A valuation survey will be conducted to derive a value set for the PBM.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, (http://creativecommons.org/licenses/by-nc-nd/4.0/) which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
Keywords: | Diabetes; Hypoglycaemia; Patient-Reported Outcome Measures; Preference-based measure; Psychometrics; Qualitative Research; Quality of Life; Health-related quality of life |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Funding Information: | Funder Grant number EUROPEAN COMMISSION - HORIZON 2020 777460 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 22 Nov 2022 14:08 |
Last Modified: | 26 Sep 2024 09:02 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1111/dme.15007 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:193397 |